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Could goat milk formula soothe fussy Babies' tummies?

NCT ID NCT07778927

Symptom relief Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial is testing whether goat milk formula can ease gastrointestinal discomfort in infants aged 0 to 5 months. Babies with symptoms like bloating, excessive crying, or spitting up will be randomly assigned to receive either goat milk or standard cow milk formula. The study will measure changes in comfort, behavior, and growth over several weeks to see if goat milk is a gentler option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Goat milk-based formula
What this could lead to
If goat milk formula proves easier to digest, it could offer a gentler feeding option for infants with gastrointestinal discomfort, improving comfort and well-being.
What could go wrong
This is an early-stage trial with a modest size, and results may not apply to all infants. Some babies may not tolerate goat milk formula, and any formula change should be discussed with a pediatrician.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 5 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infants aged 0 to 5 months at enrollment * Full-term birth (gestational age ≥37 weeks) * Birth weight ≥2500 g * Infants with symptoms of gastrointestinal discomfort (e.g., abdominal distension, excessive crying, regurgitation, or feeding intolerance) * Parents or legal guardians able and willing to provide written informed consent and comply with study procedures Exclusion Criteria: * Infants with known or suspected organic gastrointestinal diseases (e.g., congenital malformations, Hirschsprung disease) * History of severe perinatal complications or significant systemic diseases * Known or suspected cow's milk protein allergy or other food allergies * Use of antibiotics, probiotics, or other medications that may affect gastrointestinal function within 2 weeks prior to enrollment * Participation in another clinical study within the past 3 months * Any condition that, in the investigator's judgment, may interfere with study participation or outcome assessment For the reference cohort: healthy breastfed infants without significant gastrointestinal symptoms

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Conditions

The condition(s) this trial relates to.

digestive system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Functional gastrointestinal disorders (fgids) Infant discomfort

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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